MCG Diagnostics 700023-906

GUDID B3687000239060

Express Series CCM

MEDICAL GRAPHICS CORPORATION

Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system

Primary Device ID	B3687000239060
NIH Device Record Key	cc2d069b-766d-4605-91e2-a2cb97c4e113
Commercial Distribution Status	In Commercial Distribution
Brand Name	MCG Diagnostics
Version Model Number	700023-906
Catalog Number	700023-906
Company DUNS	094045622
Company Name	MEDICAL GRAPHICS CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810016250012 [Primary]
HIBCC	B3687000239060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K070858

FDA Product Code

BZL	Computer, Oxygen-Uptake

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-03-11
Device Publish Date	2019-02-23

On-Brand Devices [MCG Diagnostics]

B3687000239060	Express Series CCM
00810016251620	PREVENT II FILTER-OVAL-WHITE
00810016250289	FILTER KIT 2